Clinical trials: Mastectomy and Breast Reconstruction
Breast Cancer Classified as TNM Stage 0-IIIa
Robot-assisted vs. Open Nipple-sparing Mastectomy With Immediate Breast Reconstruction
Research Purpose The present study is designed to generate the strongest evidence available on the role of robotic surgical systems in breast cancer surgery and to elucidate the clinical value of immediate breast reconstruction…
- Trial name
- ROM (NCT05490433)
- Testing
- Robot-assisted Nipple-Sparing Mastectomy (RNSM), Conventional nipple sparing mastectomy(CNSM)
- Where
- 17 sites in South Korea
- Volunteers
- 790 people
- Sponsor
- Yonsei University
Breast Cancer, Chronic Pain
Persistent Pain After Reconstruction Following Mastectomy
A cross sectional study to determine the prevalence of persistent pain after reconstructive surgery after mastectomy for breast cancer, with a comparative analysis of a cohort treated with mastectomy without reconstruction.
- Trial name
- NCT01738048
- Testing
- Reconstruction
- Where
- Denmark
- Volunteers
- 1,352 people
- Sponsor
- Copenhagen University Hospital, Rigshospitalet
Seroma, Breast Cancer
Seroma of the Mammary Gland
The study is designed as international, prospective, minimal interventional study in cooperation with EUBREAST e.V. (European Breast Cancer Research Association of Surgical Trialists).
- Conditions
- Seroma, Breast Cancer, Mastectomy, Breast Implant; Complications
- Trial name
- SerMa (NCT05899387)
- Testing
- Swap collection, Seroma punction, Blood sampling
- Where
- Germany
- Volunteers
- 2,000 people, healthy volunteers welcome
- Sponsor
- University Hospital Augsburg
Breast Cancer, BRCA1 Mutation
Depression and Body Image Distress Following Mastectomy With Reconstruction
Mastectomy is a major surgery that can have a profound effect on women's psychosocial wellbeing, including elevated depression and body image distress.
- Conditions
- Breast Cancer, BRCA1 Mutation, BRCA2 Mutation
- Trial name
- NCT03428399
- Testing
- Psychosocial variables
- Where
- United States
- Volunteers
- 51 people
- Sponsor
- Massachusetts General Hospital
Breast/Surgery
Nipple-sparing Mastectomy in Combined With Buried Flap Monitoring
1. Learning curve of ms-Tram and DIEP breast reconstructions surgery are important to guide the training of new surgeon. 2. Buried flap post operative monitoring without implantable doppler was seldom studied, a validated…
- Trial name
- NCT05560633
- Testing
- No intervention
- Volunteers
- 147 people, healthy volunteers welcome
- Sponsor
- Sun Yat-Sen Memorial Hospital of Sun Yat-Sen University
Seroma
Arnica Montana and Bellis Perennis for Prevention of Seroma After Mastectomy
Arnica montana and Bellis perennis for Prevention of Seroma Following Mastectomy.
- Trial name
- HOM (NCT03512639)
- Testing
- Homeopathic Medication
- Volunteers
- 55 people
- Sponsor
- Shaare Zedek Medical Center
Postoperative Pain, Postoperative Nausea and Vomiting
Pre-op Paravertebral Blocks to Decrease Post-op Pain Following Mastectomy With Immediate Tissue Expander (TE) Reconstruction
Primary Objective To determine if post-operative static pain scores differ between women undergoing bilateral mastectomy followed by bilateral immediate tissue expander reconstruction randomized either to ropivacaine- (treatment)…
- Conditions
- Postoperative Pain, Postoperative Nausea and Vomiting, Quality of Life
- Trial name
- NCT02161705
- Testing
- Ropivacaine, Saline
- Where
- United States
- Volunteers
- 18 people
- Sponsor
- Johns Hopkins University
Genetic Predisposition, Breast Cancer
Pre Pectoral Implant for Immediate Breast Reconstruction Using Single Port Endoscopy in Prophylactic Indication
Implant-based reconstruction is currently the most common choice for mastectomy reconstruction. Whatever the choice of mastectomy incision, a scar remains on or near the breast volume.
- Trial name
- MRIMOP (NCT03838549)
- Testing
- Prophylactic mastectomy with immediate breast reconstruction
- Where
- France
- Volunteers
- 20 people
- Sponsor
- University Hospital, Montpellier
Mastectomy, Breast Reconstruction
Mastectomy With Retention of the Nipple-areola Complex, Robot-assisted or Not, and / or Immediate or Seconday Reconstruction by Latissimus Dorsi Flap, Robot-assisted or Not.
Phase III, non-randomized, monocentric, observational, prospective trial. It is planned to recruit a total of 480 patients, including 240 patients receiving mastectomy with preservation of the nipple-areola complex and 240…
- Trial name
- RMR (NCT04457167)
- Testing
- Robot-assisted, Not robot-assisted surgery
- Where
- France
- Volunteers
- 480 people
- Sponsor
- Institut Paoli-Calmettes
Breast Cancer
Patient Preferences for Breast Reconstruction After Mastectomy
Deciding whether or not to have breast reconstruction after mastectomy is highly challenging for many patients. This study will examine patients' decisions about reconstruction and the effects of reconstruction on quality of life…
- Trial name
- NCT01488357
- Where
- United States
- Volunteers
- 145 people
- Sponsor
- UNC Lineberger Comprehensive Cancer Center
Other Reconstructive Surgery
Use of Pulsed Electromagnetic Fields (PEMF) After Breast Reconstruction Surgery
Pedicled transverse rectus abdominus myocutaneous (TRAM) flaps are the most common post-mastectomy breast reconstructive surgeries that utilize the patient's tissue.
- Trial name
- NCT01262599
- Testing
- Ivivi Torino II PEMF Device
- Where
- United States
- Volunteers
- 32 people
- Sponsor
- Columbia University
Quality of Life, Mastectomy
Registry of Mastectomy for Breast Cancer Risk Reduction
This is a registry for patients who have a risk-reduction mastectomy ("prophylactic mastectomy") due to being at high risk for developing breast cancer, followed by breast reconstruction.
- Conditions
- Quality of Life, Mastectomy, Breast Neoplasms, Genetic Predisposition to Disease
- Trial name
- NCT00555503
- Where
- United States
- Volunteers
- 261 people
- Sponsor
- Georgetown University
Breast Cancer, Mastectomy; Lymphedema
Breast Reconstruction by Exclusive Lipomodulin : Feasibility, Evaluation of the Aesthetic Result and Quality of Life
Breast cancer is the leading female cancer in metropolitan France in terms of incidence and death. Among the therapeutic arsenal for the treatment of these cancers, surgery plays a very important role and even if a conservative…
- Trial name
- EXCLUFAT (NCT04625621)
- Where
- France
- Volunteers
- 118 people
- Sponsor
- Institut Cancerologie de l'Ouest
Breast Cancer Female
Cosmetic Outcome, Patient-reported Outcomes, and Reconstruction-related Complications in Breast Cancer Women Treated With or Without Post-mastectomy Radiation Therapy
This study aim to investigate the breast reconstruction outcome after mastectomy with or without radiation therapy from the patient's point of view.
- Trial name
- NCT03523078
- Testing
- Breast reconstructive surgery
- Where
- South Korea
- Volunteers
- 500 people
- Sponsor
- Yonsei University
Patient Satisfaction
Unilateral Secondary Breast Reconstruction Using a Muscle-sparing Pedicled Dorsal Flap After Breast Cancer
The use of pedicled dorsal flaps sparing the latissimus dorsi muscle (TDAP and MSLD flap) is a well-described reconstruction method in breast reconstruction after breast cancer.
- Trial name
- RMSU-LDPEM (NCT06230250)
- Where
- France
- Volunteers
- 22 people
- Sponsor
- University Hospital, Brest
Mastectomy; Lymphedema, Breast Cancer
Polyurethan Versus Non-polyurethan Covered Implants in Combination With Radiotherapy
The purpose of this multicenter retrospective cohort study is to determine the effect of radiotherapy on capsular contraction and implant loss rates in patients undergoing prepectoral immediate implant-based breast reconstruction…
- Trial name
- PRExRT (NCT06747065)
- Testing
- Radiotherapy
- Where
- Switzerland
- Volunteers
- 1,000 people
- Sponsor
- University Hospital, Basel, Switzerland
Breast Cancer
Use of Dermal Matrix in Breast Reconstruction
We propose to evaluate the question of whether there is a significant difference between the traditional method of serratus flap tissue expander reconstruction and the acellular matrix method.
- Trial name
- NCT00692692
- Testing
- DermaMatrix, standard of care tissue expander breast reconstruction surgery after mastectomy
- Where
- United States
- Volunteers
- 36 people
- Sponsor
- Vanderbilt University
Breast Cancer
Delayed-Immediate Breast Reconstruction
The goal of this clinical research study is to evaluate a new two-stage approach (delayed-immediate reconstruction) to breast reconstruction in women who may require post-mastectomy radiation therapy.
- Trial name
- NCT00473122
- Testing
- Delayed-Immediate Breast Reconstruction
- Where
- United States
- Volunteers
- 200 people
- Sponsor
- M.D. Anderson Cancer Center
Skin Necrosis, Complication
Efficacy of Angiography With Indocyanine Green in the Identification of Complications After Breast Surgery
During the performance of oncoplastic surgery and skin-sparing or skin-nipple mastectomy there is a significant loss in the perfusion of the cutaneous envelope of the breast, which can produce areas of vascular suffering of the…
- Trial name
- NCT05910931
- Testing
- ICG angiography
- Where
- Spain
- Volunteers
- 221 people
- Sponsor
- University Hospital A Coruña
Breast Cancer
Breast Reconstruction and Radiotherapy
If the whole breast is removed because of breast cancer, several options for breast reconstruction are available. All these options have an increased complication risk if a patient has been or will be treated with radiotherapy.
- Trial name
- CONRAD (NCT07178886)
- Where
- Netherlands
- Volunteers
- 750 people
- Sponsor
- Janine M. Simons MD PhD